[Posted 01/10/2011] ISSUE: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDA’s unapproved drugs initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.

RECOMMENDATION: See Roxane’s “Dear Healthcare Professional Letter” for a complete description and photos of labeling and product packaging changes. Changes include:

A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” is displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.

A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) from other morphine sulfate oral solutions marketed by Roxane with a white background.

The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.

A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.

Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors from occurring.

Healthcare providers should discuss the correct use of the oral syringe with their patients.

For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for morphine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of morphine and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

Close

What is this medicine?

MORPHINE (MOR feen) is a pain reliever. It is used to treat moderate to severe pain that lasts for more than a few days.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

brain tumor

drug abuse or addiction

head injury

heart disease

if you frequently drink alcohol-containing drinks

intestinal disease

kidney disease or problems urinating

kyphoscoliosis

liver disease

lung disease, asthma, or breathing problems

seizures

taken isocarboxazid, phenelzine, tranylcypromine, or selegiline in the past 2 weeks

an unusual or allergic reaction to lactose, morphine, other medicines, foods, dyes, or preservatives

pregnant or trying to get pregnant

breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not break, crush, or chew the medicine. Do not take a tablet that is not whole. A broken or crushed tablet can be very dangerous. You may get too much medicine. If the medicine upsets your stomach, take it with food or milk. Follow the directions on the prescription label. Take the medicine at the same time each day. Do not take more medicine than you are told to take.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

alcohol

antihistamines

barbiturates, like phenobarbital

medicines for depression, anxiety, or psychotic disturbances

medicines for sleep

muscle relaxants

naltrexone, naloxone

narcotic medicines (opiates) for pain

rifampin

tramadol

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Your mouth may get dry. Drinking water, chewing sugarless gum, or sucking on hard candy may help. See your dentist every 6 months.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

breathing problems

change in the amount of urine

confusion

fever, chills

hallucinations

feeling faint or lightheaded

red or sore at the injection site

seizures

slow or fast heartbeat

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

constipation

dizzy, drowsy

headache

nausea, vomiting

pinpoint pupils

sweating

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.

Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages. Flush any unused medicine down the toilet. Do not use the medicine after the expiration date. Follow the directions in the MedGuide.

Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.

The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks,
and other material contained on the Healthline Site ("Content"), its services, and any information or material
posted on the Healthline Site by third parties are provided for informational purposes only. None of the
foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek
the advice of a physician or other qualified healthcare provider with any questions you may have regarding a
medical condition. Never disregard professional medical advice or delay in seeking it because of something you
have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately.
Please read the Terms of Service
for more information regarding use of the Healthline Site.

Healthline’s mission is to make the people of the world healthier through the power of information. We do this by creating quality health information that is authoritative, approachable, and actionable.

Join more than 30 million monthly visitors like you and let Healthline be your guide to better health.